Enbrel(etanercept)
Enbrel, Erelzi (etanercept) is a protein pharmaceutical. Etanercept was first approved as Enbrel on . It is used to treat ankylosing spondylitis, juvenile arthritis, psoriatic arthritis, and rheumatoid arthritis in the USA. It has been approved in Europe to treat ankylosing spondylitis, juvenile arthritis, psoriasis, psoriatic arthritis, and rheumatoid arthritis amongst others. The pharmaceutical is active against tumor necrosis factor.
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Commercial
Trade Name
FDA
EMA
Enbrel, Erelzi (discontinued: Erelzi, Erelzi sensoready, Eticovo)
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| enbrel | Biologic Licensing Application | 2021-12-13 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| ankylosing spondylitis | EFO_0003898 | D013167 | M45 |
| juvenile arthritis | EFO_0002609 | D001171 | M08 |
| psoriatic arthritis | EFO_0003778 | D015535 | L40.5 |
| rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
etanercept, Enbrel, Immunex Corporation | |||
| 2106-05-27 | Orphan excl. | ||
etanercept, Enbrel Mini, Immunex Corporation | |||
| 2106-05-27 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1438 | Injection, etanercept, 25 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered) |
Clinical
Clinical Trials
382 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 7 | 6 | 33 | 47 | 34 | 126 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 3 | 5 | 32 | 27 | 21 | 85 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | 2 | 9 | 17 | 13 | 40 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | — | 6 | 7 | 10 | 23 |
| Juvenile arthritis | D001171 | EFO_0002609 | M08 | 1 | 2 | 7 | 2 | 2 | 13 |
| Spondylarthritis | D025241 | — | 2 | 1 | 4 | 1 | 7 | ||
| Spondylarthropathies | D025242 | EFO_0000706 | M47 | — | 1 | 1 | 3 | 1 | 5 |
| Rheumatic fever | D012213 | EFO_1001160 | I00-I02 | — | — | 1 | 1 | — | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | 1 | 1 | 2 |
| Gout | D006073 | EFO_0004274 | M10 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 6 | 9 | 2 | — | — | 12 |
| Inflammation | D007249 | — | 1 | 1 | — | 2 | 4 | ||
| Neoplasms | D009369 | C80 | 3 | 1 | 1 | — | — | 4 | |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | 1 | 1 | — | 3 | 4 |
| Prostatic neoplasms | D011471 | C61 | 1 | 1 | 1 | — | — | 2 | |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | 1 | 1 | — | 1 | 2 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | 1 | 1 | — | — | 2 |
| Dermatomyositis | D003882 | EFO_0000398 | M33 | 1 | 1 | 1 | — | — | 2 |
| Granulomatosis with polyangiitis | D014890 | EFO_0005297 | M31.3 | — | 2 | 1 | — | — | 2 |
| Stevens-johnson syndrome | D013262 | EFO_0004276 | L51.1 | — | — | 1 | — | — | 1 |
Show 13 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 10 | 2 | — | — | — | 12 | ||
| Myelodysplastic syndromes | D009190 | D46 | 2 | 5 | — | — | — | 5 | |
| Leukemia | D007938 | C95 | 1 | 4 | — | — | — | 4 | |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 3 | 1 | — | — | — | 4 |
| Graft vs host disease | D006086 | D89.81 | — | 4 | — | — | — | 4 | |
| Hidradenitis suppurativa | D017497 | L73.2 | — | 2 | — | — | 1 | 3 | |
| Myelodysplastic-myeloproliferative diseases | D054437 | 1 | 2 | — | — | — | 2 | ||
| Discoid lupus erythematosus | D008179 | L93.0 | — | 2 | — | — | — | 2 | |
| Asthma | D001249 | EFO_0000270 | J45 | — | 1 | — | — | 1 | 2 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | 1 | 2 | — | — | — | 2 |
Show 36 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | — | — | — | 1 | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | — | — | 1 | 2 |
| Metabolic bone diseases | D001851 | HP_0000938 | 1 | — | — | — | — | 1 | |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | 1 | — | — | — | — | 1 |
| Persian gulf syndrome | D018923 | EFO_0007430 | 1 | — | — | — | — | 1 | |
| Occupational diseases | D009784 | 1 | — | — | — | — | 1 | ||
| Castration-resistant prostatic neoplasms | D064129 | 1 | — | — | — | — | 1 | ||
| Therapeutic equivalency | D013810 | 1 | — | — | — | — | 1 | ||
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | 1 | — | — | — | — | 1 |
| Lymphoma | D008223 | C85.9 | 1 | — | — | — | — | 1 |
Show 2 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | — | — | 2 | 2 |
| Papulosquamous skin diseases | D017444 | L40-L45 | — | — | — | — | 2 | 2 | |
| Infections | D007239 | EFO_0000544 | — | — | — | — | 1 | 1 | |
| Behcet syndrome | D001528 | EFO_0003780 | M35.2 | — | — | — | — | 1 | 1 |
| Uveal diseases | D014603 | — | — | — | — | 1 | 1 | ||
| Postoperative pain | D010149 | G89.18 | — | — | — | — | 1 | 1 | |
| Inguinal hernia | D006552 | HP_0000023 | K40 | — | — | — | — | 1 | 1 |
| Bronchitis | D001991 | J40 | — | — | — | — | 1 | 1 | |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | — | — | — | — | 1 | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ETANERCEPT |
| INN | etanercept |
| Description | Etanercept, sold under the brand name Enbrel among others, is a biopharmaceutical that treats autoimmune diseases by interfering with tumor necrosis factor (TNF, a soluble inflammatory cytokine) by acting as a TNF inhibitor. It has U.S. F.D.A. approval to treat rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. TNF-alpha is the "master regulator" of the inflammatory (immune) response in many organ systems. Autoimmune diseases are caused by an overactive immune response. Etanercept has the potential to treat these diseases by inhibiting TNF-alpha.
|
| Classification | Protein |
| Drug class | receptor molecules or membrane ligands, natural, modified or modified: tumor necrosis factor receptors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 185243-69-0 |
| RxCUI | 214555 |
| ChEMBL ID | CHEMBL1201572 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00005 |
| UNII ID | OP401G7OJC (ChemIDplus, GSRS) |
Target
Agency Approved
TNF
TNF
Organism
Homo sapiens
Gene name
TNF
Gene synonyms
TNFA, TNFSF2
NCBI Gene ID
Protein name
tumor necrosis factor
Protein synonyms
APC1 protein, Cachectin, TNF, macrophage-derived, TNF, monocyte-derived, TNF-a, TNF-alpha, tumor necrosis factor ligand 1F, Tumor necrosis factor ligand superfamily member 2, tumor necrosis factor-alpha, tumor necrotic factor alpha
Uniprot ID
Mouse ortholog
Tnf (21926)
tumor necrosis factor (P06804)
Alternate
No data
Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
|---|---|---|---|---|
| VCV000225964 | TNF, -488G>A | drug response | 2021-03-24 | 2B |
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Enbrel - Pfizer
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Enbrel - Amgen
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 25,251 documents
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Safety
Black-box Warning
Black-box warning for: Enbrel
Adverse Events
Top Adverse Reactions
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2,884 adverse events reported
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